Investigating the effects of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on paediatric acute-onset neuropsychiatric syndrome (PANS): An open-label study.

Abstract

This is an 18 to 54-week open-label study to evaluate the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of paediatric acute-onset neuropsychiatric syndrome (PANS) in children.

The purpose of this study is to determine how effective NTI164 is in patients with PANS when treated for 18 to 54 weeks.

Participants will commence treatment with a daily dose of 5mg/kg of NTI164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase). Participants who wish to continue receiving their maximum tolerated dose beyond the 8-week Treatment phase may do so for up to fifty-four (54) weeks (Extension phase). At the end of the Treatment or Extension phase, participants will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase).

Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the emotions and behaviour of patients with PANS.

Whole blood RNA sequencing will validate the immune dysfunction signature.